BEUDAMED
    41 results · 20ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii ×

    Dimension IRON Flex reagent cartridges

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·November 23, 2016

    Dimension Vista IRON Flex reagent cartridges

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·November 23, 2016

    ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·April 12, 2017

    Immunoradiometric assay.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics·January 16, 2013

    Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·August 6, 2014

    ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc·November 26, 2014

    Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·April 10, 2013

    Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·April 10, 2013

    Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·April 10, 2013

    Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2013

    Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics·January 16, 2013

    Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics·January 16, 2013

    Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·August 15, 2012

    Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics Inc·August 31, 2016

    IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE¿ Systems Analyzers  for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·November 19, 2014

    Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics Inc·January 16, 2013

    Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics Inc·January 16, 2013

    Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·January 16, 2013

    The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·February 22, 2017

    The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·February 22, 2017